The Mother in Norway Study

Phase

N/A

Condition

N/A

Treatment

Nurse-Family Partnership

Clinical Study ID

NCT05895604

NFP-202862

Ages > 16
Female
Accepts Healthy Volunteers

Study Summary

The Norwegian government is implementing the Nurse Family Partnership program (NFP) to combat child abuse and social inequality. This study will examine NFP with an individually randomized controlled parallel-group trial. The study will enroll 700 mothers over two years, with half receiving NFP services and the other half receiving standard care. The primary outcome is violence towards mothers and their children, assessed through questionnaires and observation tests. The study will also evaluate the program's effects on various health-related outcomes using administrative data. Cost-effectiveness analyses will be conducted to compare NFP to existing services and improve its delivery efficiency.

Eligibility Criteria

Inclusion

Inclusion Criteria: Female; No previous live births; Currently pregnant; Gestation periodless than 28 weeks (i.e., less than or equal to 27 weeks, 6 days) at time of recruitment;Live within an area serviced by a NFP Implementing Agency; Not currently enrolled in thestudy; professionals are concerned about the pregnancy / impending parenthood

Exclusion

Exclusion Criteria: Women who have had a previous live birth; Women who are not currentlypregnant; Women who are past their 28th week of gestation (i.e., greater than or equal to 28 weeks, 0 days) at time of recruitment; Women who live outside of an area serviced by aNFP Implementing Agency; Women who are currently enrolled in the study; professionals arenot concerned about the pregnancy / impending parenthood

Study Design

Nurse-Family Partnership

June 01, 2023

December 31, 2042

Study Description

The Norwegian government has since 2015 been in the process of implementing the Nurse Family Partnership program (NFP) in Norway, as a possibly important part in their strategy to combat child abuse and social inequality. This study employs an individually randomized controlled parallel-group trial where participants are randomly assigned to experimental and control groups. The planned study population is 700 mothers total (350 in the treatment group and 350 in the control group) to be enrolled over 2 years (June 2023 -2025), with NFP services delivered to the treatment group through the children's second birthday (2025-2028). The control group will receive the standard of care and whatever other programs and services are available in the community.

Primary outcome is violence towards first-time mothers and their children. In their last trimester, and when the child is 6, 12 and 24 months old, mothers included in the study will receive a questionnaire assessing perceived partner violence, parenting skills, coping, control, and the child's development and language. At 24 months, staff at health stations will perform the Bayley observation test of the child´s development and language. The study will also utilise administrative data to assess the effects of NFP on a wide range of health- and health related outcomes. All analyses are carried out blinded. The investigators estimate "intention-to-treat" (ITT) effects and per-protocol analysis. Cost-effectiveness analyses will be conducted to compare the value of NFP to existing services, and to improve the efficiency in the delivery of NFP.

Connect with a study center

Region Vestland
Bergen, 5009
Norway
Active - Recruiting
Region Agder
Kristiansand, 4630
Norway
Active - Recruiting
Region Oslo
Oslo, 0188
Norway
Active - Recruiting
Region Rogaland
Sandnes, 4307
Norway
Active - Recruiting
Region Trøndelag
Trondheim, 7004
Norway
Active - Recruiting

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